ENSWELL— 510(k) K831899

Name: FDA 510(k) clearance K831899
Creator: U.S. Food and Drug Administration
Published: 1983-07-07

Substantially Equivalent

Dr. Micheal A. Sabia

FDA 510(k) clearance K831899 for ENSWELL, Substantially Equivalent on 1983-07-07. Applicant: Dr. Micheal A. Sabia. Device class: 1.

Clearance details

Applicant: Dr. Micheal A. Sabia
Product code: Code IME
Device class: Class 1
Regulation: 21 CFR 890.5700
Advisory panel: Physical Medicine
Date received: 1983-06-14
Decision date: 1983-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K831898 — SCOLIMETER1983-07-19

Adverse events under product code IME

product code IME

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.